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Associate Director For Our DS Compliance & Support Area

Build and implement support systems for new biologics manufacturing facility
Hillerød, Capital Region of Denmark, Denmark
Senior
15 hours agoBe an early applicant
FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies

A global contract development and manufacturing organization specializing in biologics and advanced therapies.

1 Similar Job at FUJIFILM Diosynth Biotechnologies

Associate Director For MilkyWay Production Facility

Are you a passionate leader? Do you want a role with great organizational impact? Then join our dynamic and forward-thinking organization as we embark on an exciting journey with our new production facility, MilkyWay. We are committed to excellence, innovation, and seamless collaboration.

The Role

We are seeking an experienced and visionary Associate Director to lead the transition and integration of our MilkyWay production facility with our current Drug Substance (DS) operations.

The role is anchored in DS Compliance and Support leadership team. You will be responsible for building up a team that will provide support to MilkyWay until it is operational. You will be the point of contact between MilkyWay and the DS Compliance and Support organization. The main idea is that daily operations in DS Compliance & Support runs smoothly supporting running operation and at the same time is the leadership, competency and alignment anchor for MilkyWay. The 2 new production lines in MilkyWay will be operational with ½ a year apart in 2026 and 2027. After MilkyWay is operational the established teams as well as the position as Associate Director will be reorganized to fit into current organization.

Key Responsibilities

In alignment with the project plan for MilkyWay and in collaboration with DS Compliance and Support you will be driving the people leadership incl. recruitment and onboarding of the support team, as well as the planning and follow up on support deliverables. The key support activities to be provided to MilkyWay are:

  • Preparing SOPs and work instructions for the new facility
  • Structure the training activities for onboarding of the workforce to MilkyWay
  • Preparing the electronic batch records and solution records for the qualification and validation activities
  • Campaign Readiness activities, including being the link between Tech Transfer and MilkyWay

To deliver products of high quality we must constantly improve the way we work. Therefore, the job requires that you are passionate about driving the right culture to ensure that we are constantly improving our current state. Focus on safety, quality and efficient Drug Substance delivery are key focus areas.

You will be expected to maintain visibility and approachability at our facility in Hillerød, offering support and encouraging open communication within your team as well as with your stakeholders.

Experience in Leadership and Project Management

We are looking for a candidate who brings 5+ years of leadership experience and project management experience. We expect that your educational background and/or knowledge lies within the pharmaceutical industry. Additionally, you bring in:

  • A good understanding and experience with complex processes and change management.
  • Quality mindset and GxP experience from the pharmaceutical industry
  • A role model and practices visible leadership (gemba walks, participate in board meetings etc.)
  • Talent to build trust and psychological safety at all organizational levels.
  • English skills, fluent spoken and written.

As a person you approach leadership and people with openness and positive energy, and through your leadership style, you bring people together and lift up those around you. You are a natural self-starter and have a systematic, dynamic approach to work. Lastly, if you see yourself as a high performing team player who is ambitious on behalf of yourself and the company, then you might be just the candidate we are looking for! Interested? If you have clarifying questions about this unique position, please reach out to Director, DS Compliance & Support, Karin Toftegaard on +45 2236 4617. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.

Working at FUJIFILM Biotechnologies We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen. FUJIFILM Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world's most innovative biotech and biopharma companies reimagining healthcare's potential. We work across the entire lifecycle of our customers' products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another's passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives. Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team. We offer the chance to be part of a global workplace where passion, drive, and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations. We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package. FUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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Associate Director For Our DS Compliance & Support Area
Hillerød, Capital Region of Denmark, Denmark
Support
About FUJIFILM Diosynth Biotechnologies
A global contract development and manufacturing organization specializing in biologics and advanced therapies.